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Drug Labeling Inside the Box


Reading those lengthy package inserts about the medicines you're taking is a bit like eating peas.'  You know they are good for you, but your gut says 'yuck.''  So odds are you don't bother with all that teensy-tiny fine print, but just take the medicine and hope for the best.

Not long ago an eye doctor gave me a sample of Biotrue, a multipurpose solution for contact lenses.'  Its advantage was the size of the bottle'small enough to get through airport carry-on screening.'  But I needed to know if it would cause an allergic reaction.

So I looked for the package insert and finding none, I threw away the box.'  Just as it hit the bottom of the garbage can, bingo, I noticed a bunch of really teensy-tiny type on the inside of the box'a new version of the information insert only far less readable.'  It was not helpful, either.'  It advised not using the product if I were allergic to any of the ingredients listed four paragraphs above, and those read like a chemistry teacher's shopping list. ' ' How could I remember what was in other products that made my eyes red and itchy?

Campaign for Clarity

Dartmouth researchers Lisa Schwartz and Steve Woloshin are on a mission to get drug makers to simplify their inserts and yes, put them on the inside of the box.'  In a recent New York Times op-ed, they argue that a body of published peer-reviewed research shows that information on drug boxes can improve consumer-decision making.'  That's all to the good but it is not just where the information is placed'but what information is provided.

Schwartz and Woloshin offer a solution:'  a label that might fit on the inside of the box and that tells patients quickly what they really need to know.'  As a sample, they used the drug Abilify, an antidepressant, and broke it down into four components:'  what difference the drug makes; how it helps; what are its serious side effects; and what are the symptoms of side effects.'  There's also a warning box.'  Those cautions are important. ' If consumers easily learned of' the side effects and warnings for one drug, they might be able to more readily compare them with side effects of another while at the same time, factoring in cost information for alternatives or substitutes.

Information about the drug in this simple format would certainly mean more to me than a laundry list of chemicals I cannot relate to.'  And all of this is, of course, probes behind the ubiquitous TV ads whose objective is to get you to ask your doctor for the drug being promoted.'  The ads often don't tell how well a drug actually works'key information, you would think.

Comparing Drugs

The Dartmouth researchers say that the government already requires disclosure of important side effects, but there's no rule that prescribes how drug makers should provide the information and no requirement that they have to disclose how well drugs work compared to placebos or other similar drugs.'  These data can be hard to find'even for doctors.'  The health reform law requires the Department of Health and Human Services (HHS) to evaluate how drug fact boxes work and recommend to Congress whether to require them.'  HHS says it needs at least three more years to make a decision.

If Biotrue is any example, more progressive drug makers may not wait for regulations. ' And maybe'just maybe'they will put the stuff in plain English and consider the recommendations of Schwartz and Woloshin.'  I really would like to try Bausch & Lomb's product, but now I don't know enough to take a chance.

If drug makers do move to inside-the-box facts, patients need to know they are there.'  Otherwise they will end up in the trash as Biotrue's almost did.

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More Blog Posts by Trudy Lieberman

author bio

Trudy Lieberman, a journalist for more than 40 years, is an adjunct associate professor of public health at Hunter College in New York City. She had a long career at Consumer Reports specializing in insurance, health care, health care financing and long-term care. She is a longtime contributor to the Columbia Journalism Review and blogs for its website,, about media coverage of health care, Social Security and retirement. As a William Ziff Fellow at the Center for Advancing Health, she contributes regularly to the Prepared Patient Blog. Follow her on twitter @Trudy_Lieberman.

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Just Say â??Knowâ?? to Drugs: A Proposal to Improve Prescription Drug Information | says
September 6, 2011 at 3:18 PM

[...] how well their prescription drugs actually work have been waylaid by competing interests for years, with only modest hope of progress in [...]